About this trial
Phase III, open label, randomised, multicentre, blind for evaluators clinical trial to evaluate the efficacy of esketamine nasal spray at flexible dosis compared to aripiprazole in elderly participants (\>60 years) who suffer from treatment-resistant major depressive
Eligibility criteria
Qualifiers
Patients between 60-74 years
To be receiving antidepressant treatment that includes an antidepressant at the time of screening that is not responding (less than 25% improvement in symptoms) after receiving an adequate dose [or local equivalent, if applicable] for at least 6 weeks and have been increased to the dose maximum allowed
Current antidepressant treatment must have been immediately preceded by failure to respond to at least 3, but not more than 5, different consecutive treatments (all within the same moderately severe depressive episode) with antidepressant drugs (AD) taken at an appropriate dose for at least least 6 weeks (3 antidepressant failures including the current one)
To have been treated with at least 3 different classes of antidepressants between treatments taken at appropriate doses for at least 6 weeks without response in the current moderate to severe depressive episode (including current treatment with an antidepressant)
Disqualifiers
Treatment with drugs contraindicated with the use of esketamine and aripiprazole.
Patients in whom a high risk of suicide is detected at the screening visit, according to the criteria established by Columbia University according to the C-SSRS evaluation
Patients who are participating in another clinical trial with active treatment
Patients who do not have the capacity to consent to participation in the trial or who do not have a representative to confirm their participation
Trial design
Treatments tested in this trial
- Experimental regimen
- Control regimen